WO2023278363A1 - Dispositif d'accès vasculaire à avancement de fil-guide sans contact - Google Patents

Dispositif d'accès vasculaire à avancement de fil-guide sans contact Download PDF

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Publication number
WO2023278363A1
WO2023278363A1 PCT/US2022/035196 US2022035196W WO2023278363A1 WO 2023278363 A1 WO2023278363 A1 WO 2023278363A1 US 2022035196 W US2022035196 W US 2022035196W WO 2023278363 A1 WO2023278363 A1 WO 2023278363A1
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WO
WIPO (PCT)
Prior art keywords
access device
housing
vascular access
wedge
loop
Prior art date
Application number
PCT/US2022/035196
Other languages
English (en)
Inventor
Megan Scherich
Jonathan Karl Burkholz
Original Assignee
Becton, Dickinson And Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Becton, Dickinson And Company filed Critical Becton, Dickinson And Company
Priority to EP22834018.8A priority Critical patent/EP4363023A1/fr
Priority to JP2024500002A priority patent/JP2024524504A/ja
Priority to MX2023015389A priority patent/MX2023015389A/es
Publication of WO2023278363A1 publication Critical patent/WO2023278363A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150221—Valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150992—Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154—Devices using pre-evacuated means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0113—Mechanical advancing means, e.g. catheter dispensers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires

Definitions

  • Catheters are commonly used for a variety of infusion therapies.
  • catheters may be used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient.
  • catheters may also be used for withdrawing blood from the patient.
  • a common type of catheter device includes a catheter that is over-the-needle.
  • the catheter that is over-the-needle may be mounted over an introducer needle having a sharp distal tip.
  • a catheter assembly may include a catheter hub, the catheter extending distally from the catheter hub, and the introducer needle extending through the catheter.
  • the catheter and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from skin of the patient.
  • the catheter and introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient.
  • a clinician In order to verify proper placement of the introducer needle and/or the catheter in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter assembly. Once placement of the needle has been confirmed, the clinician may temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.
  • a fibrin sheath or thrombus may form on an internal surface of the catheter assembly, an external surface of the catheter assembly, or within the vasculature near or downstream of the distal tip of the catheter.
  • the fibrin sheath or thrombus may block or narrow a fluid pathway through the catheter, which may impair infusion and/or collection of a high-quality blood sample.
  • a vascular access device may include an advancement element and a housing extending through the advancement element.
  • the housing may include a lumen extending therethrough, which may be used for blood collection.
  • the vascular access device may include a pair of opposing pinch members configured to pinch the housing, which may include an extension tube.
  • the pair of opposing pinch members may be disposed within the advancement element and configured to move along the housing with the advancement element.
  • the vascular access device may include a guidewire, which may include a distal end and a proximal end.
  • the proximal end of the guidewire may include a wedge.
  • the guidewire may be disposed within the lumen.
  • the pair of opposing pinch members in response to moving the advancement element distally along the housing, the pair of opposing pinch members may move the wedge distally and the guidewire may be advanced distally.
  • the wedge may be monolithically formed as a single unit with the distal end of the guidewire.
  • the wedge may be cylindrical.
  • an outer surface of the wedge may include one or more grooves configured to allow fluid to pass the wedge.
  • the wedge may include one or more fins.
  • the wedge may be spherical or cylindrical.
  • the wedge may be constructed of metal or another suitable material.
  • the pair of opposing pinch members may be disposed within the advancement element proximal to the wedge.
  • the vascular access device may include another pair of opposing pinch members configured to pinch the housing.
  • the other pair of opposing pinch members may be disposed within the advancement element distal to the wedge and configured to move along the housing with the advancement element, wherein in response to moving the advancement element proximally along the housing, the pair of opposing pinch members may move the wedge proximally and the guidewire may be retracted proximally.
  • an inner surface of the advancement element may include multiple bumps in contact with the pair of opposing pinch members, which may reduce friction.
  • the vascular access device may include a distal adapter configured to couple to a catheter assembly.
  • a distal end of the housing may be coupled to the distal adapter.
  • the distal adapter may include a shaft and opposing lever locks.
  • the vascular access device may include a proximal connector coupled to a proximal end of the housing.
  • the proximal connector may be configured to couple to a blood collection device.
  • the guidewire may be coiled to form the wedge.
  • the proximal end of the guidewire may include a looped portion formed by the guidewire.
  • the guidewire may be disposed within the lumen.
  • the pair of opposing pinch members in response to moving the advancement element distally along the housing, may be aligned with an opening formed by the looped portion and may advance the guidewire distally.
  • the looped portion may include a single loop.
  • the single loop may be circular or ovular.
  • the looped portion may include multiple loops that may be stacked.
  • each of the loops may be circular or ovular.
  • the guidewire may include a twist portion proximate the looped portion.
  • a first end and a second end of the looped portion may be twisted together to form the twist portion.
  • the loops may include one or more of a first loop, a second loop, and a third loop.
  • the loops may include the first loop and the second loop, and the first end of the looped portion may be proximate the first loop and the second end of the looped portion may be proximate the second loop.
  • the loops may include the first loop, the second loop, and the third loop, and the second loop may be in between the first loop and the third loop.
  • the first end of the looped portion may be proximate the first loop and the second end of the looped portion may be proximate the third loop.
  • the looped portion may include a coating.
  • Figure 1A is an upper perspective view of an example vascular access device, illustrating an example advancement element in an example retracted position, according to some embodiments;
  • Figure IB is an upper perspective view of the vascular access device, illustrating the advancement element in an example advanced position, according to some embodiments;
  • Figure 2A is a cross-sectional view of the vascular access device, according to some embodiments;
  • Figure 2B is an upper perspective view of an example guidewire, according to some embodiments.
  • Figure 2C is an example proximal end of the guidewire, according to some embodiments.
  • Figure 2D is another example proximal end of the guidewire, according to some embodiments.
  • Figure 2E is another example proximal end of the guidewire, according to some embodiments.
  • Figure 2F is an upper perspective view of an example piece of the advancement element, according to some embodiments.
  • Figure 2G is an upper perspective view of another example piece of the advancement element, configured to couple to the piece of Figure 2F, according to some embodiments;
  • Figure 3A is an upper perspective view of the guidewire, illustrating an example spherical proximal end, according to some embodiments;
  • Figure 3B is a cross-sectional view of the advancement element, illustrating the spherical proximal end, according to some embodiments;
  • Figure 4A is a top view of the guidewire, illustrating an example looped portion including an example single loop, according to some embodiments;
  • Figure 4B is a side view of the guidewire, illustrating the looped portion including the single loop, according to some embodiments;
  • Figure 4C is another top view of the guidewire, illustrating an example coating on the single loop, according to some embodiments.
  • Figure 4D is a cross-sectional view of the advancement element, illustrating the looped portion including the single loop, according to some embodiments;
  • Figure 5A is a side view of the guidewire, illustrating the looped portion including an example first loop and an example second loop, according to some embodiments;
  • Figure 5B is a top view of the guidewire, illustrating the looped portion including the first loop, the second loop, and the coating, according to some embodiments;
  • Figure 5C is a cross-sectional view of the advancement element, illustrating the looped portion including the first loop and the second loop, according to some embodiments;
  • Figure 6A is a side view of the guidewire, illustrating the looped portion including the first loop, the second loop, and an example third loop, according to some embodiments;
  • Figure 6B is a cross-sectional view of the advancement element, illustrating the looped portion including the first loop, the second loop, and the third loop, according to some embodiments;
  • Figure 7 is an upper perspective view of the guidewire, illustrating an example coiled portion, according to some embodiments.
  • Figure 8A is an upper perspective view of the vascular access device coupled to an example catheter assembly having a first configuration, according to some embodiments; and [0039] Figure 8B is an upper perspective view of the vascular access device coupled to the catheter assembly having a second configuration, according to some embodiments.
  • the vascular access device 10 may include an advancement element 12 and a housing 14 extending through the advancement element 12.
  • the housing 14 may include an extension tube, which may be flexible or semi-flexible.
  • the housing 14 may include a coextruded guidewire to add stiffness to the housing 14.
  • the housing 14 may include a multi- lumen extension tube, which may be described further in U.S. Patent App. No. 17/574,127, filed January 12, 2022, which is hereby incorporated by reference in its entirety.
  • the vascular access device 10 may include a guidewire 16, which may be constructed of metal or another suitable material.
  • the guidewire may be lubricated or coated to ease advancement. Over time a catheter can become occluded at a catheter distal tip due to presence of fibrin sheath, thrombus, or vein walls or valves.
  • the guidewire 16 may be configured to extend into and/or through the catheter assembly to push through and/or disrupt an occlusion of the catheter when the vascular access device 10 is coupled to a catheter assembly that includes the catheter.
  • the guidewire 16 may be configured to advance distally through the catheter assembly and into the vasculature of the patient to overcome thrombus and fibrin sheath in or around the catheter assembly or in the vein that might otherwise prevent blood draw.
  • the guidewire 16 may be replaced by another suitable instrument, such as, for example, a tube.
  • the other suitable instrument may be similar or identical to the guidewire 16 in terms of one or more components and/or operation.
  • the advancement element 12 may be configured to move between a retracted position illustrated, for example, in Figure 1A, and an advanced position, illustrated, for example, in Figure IB.
  • the retracted position may correspond to an initial position of the advancement element 12.
  • the clinician may pinch or grasp the advancement element 12 to move the advancement element 12 between the retracted position and the advanced position.
  • a distal end of the guidewire 16 may move from inside the housing 14 to outside of the housing 14.
  • a distal end 22 of the vascular access device 10 may include a distal connector 24.
  • the distal connector 24 may include opposing lever arms 26a, 26b.
  • distal ends of the opposing lever arms 26a, 26b may be configured to move apart from each other in response to pressure applied to proximal ends of the opposing lever arms 26a, 26b.
  • the distal ends of the opposing lever arms 26a, 26b may move closer to each other and clasp a portion of the catheter assembly, such as a needleless connector, another connector, or a proximal end of a catheter hub, for example.
  • the distal connector 24 may include a blunt cannula or male luer configured to insert into the portion of the catheter assembly.
  • the distal connector 24 may include any suitable connector.
  • the distal connector 24 may include a threaded male luer, a slip male luer, a threaded male luer with a spin lock, a threaded male luer with a removable blunt cannula snap connection, a slip male luer with a removable blunt cannula snap connection, or another suitable connector.
  • the distal connector 24 may include one or more bond pockets, which may each be configured to receive an extension tube, which may be part of the catheter assembly or extend between the distal connector 24 and the catheter assembly.
  • the distal connector 24 may be monolithically formed as a single unit with the housing 14.
  • the distal connector 24 may be configured to couple to the catheter assembly, which may be existing or already dwelling within the vasculature of the patient.
  • the catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter.
  • the catheter may extend from the distal end of the catheter adapter.
  • the catheter may include a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter.
  • the catheter assembly may include an introducer needle, which may extend through the catheter and facilitate piercing of skin and the vasculature to insert the catheter into the patient.
  • the introducer needle may be removed from the catheter assembly prior to coupling of the vascular access device 10 to the catheter assembly.
  • the catheter assembly may be straight. In other embodiments, the catheter assembly may be integrated, having an extension tube that is integrated with the catheter adapter. Thus, a configuration may vary, according to some embodiments.
  • the catheter assembly may include an extension set, which may include the extension tube extending from and integrated with a side port of the catheter adapter.
  • the distal adapter 18 may be configured to couple to a portion of the catheter assembly, such as the proximal end of the catheter adapter and/or a needleless access connector.
  • the needleless access connector may be coupled to a proximal end, a T- connector, or another portion of the catheter assembly.
  • the needleless access connector may be permanently connected, such as, for example, via adhesive, to the distal adapter 18 to prevent intentional or unintentional removal by a user.
  • a proximal end 28 of the vascular access device 10 may include a needleless connector 29 and/or a proximal connector 30, which may be similar to identical to the distal connector 24 or may include another suitable connector.
  • the proximal connector 30 may be configured to couple to a blood collection device.
  • the blood collection device may include a syringe, a BD VACUTAINER ® one-use holder (available from Becton, Dickinson and Company of Franklin Lakes, New Jersey), a BD VACUTAINER ® LUER-LOKTM access device (also available from Becton, Dickinson and Company of Franklin Lakes, New Jersey), or another suitable blood collection device, which may provide suction.
  • a BD VACUTAINER ® one-use holder available from Becton, Dickinson and Company of Franklin Lakes, New Jersey
  • BD VACUTAINER ® LUER-LOKTM access device also available from Becton, Dickinson and Company of Franklin Lakes, New Jersey
  • another suitable blood collection device which may provide suction.
  • the proximal connector 30 may be coupled to the blood collection device via the needleless connector 29, which may be disposed in between the blood collection device and the needleless connector 29.
  • the blood collection device and the proximal connector 30 may be monolithically formed as a single unit.
  • the proximal connector 30 may be monolithically formed as a single unit with the housing 14.
  • the housing 14 may include a lumen 31 extending through the housing 14.
  • a blood collection pathway through which blood flows during blood collection from the catheter assembly may include the distal connector 24, the lumen 31, and the proximal connector 30.
  • the guidewire 16 may be moved to the advanced position prior to or during blood draw.
  • the user may retract the guidewire 16 into the housing 14 by moving the advancement element towards the user or proximally.
  • a risk of exposure of the user to blood may be decreased.
  • a proximal end of the guidewire 16 may include a wedge 32 disposed within the advancement element 12 and the lumen 31 of the housing 14.
  • the vascular access device 10 may include one or more pairs of opposing pinch members 34 configured to pinch the housing 14.
  • the pair of opposing pinch members 34a, b may be disposed within the advancement element 12 proximal to the wedge 32 and configured to move along the housing 14 with the advancement element.
  • the pair of opposing pinch members 34a, b in response to moving the advancement element distally along the housing 14, the pair of opposing pinch members 34a, b may compress the housing 14 to push the wedge 32 distally, and the guidewire 16 may be advanced distally.
  • the vascular access device 10 may include another pair of opposing pinch members 34c, d configured to pinch the housing 14.
  • the other pair of opposing pinch members 34c, d may be disposed within the housing distal to the wedge 32 and configured to move along the housing 14 with the advancement element.
  • the pair of opposing pinch members 34c, d in response to moving the advancement element proximally along the housing 14, the pair of opposing pinch members 34c, d may compress the housing 14 and push the wedge 32 proximally and the guidewire 16 may be retracted proximally.
  • the pair of opposing pinch members 34a, b and the other pair of opposing pinch members 34c, d may be referred to collectively in the present disclosure as “opposing pinch members 34.”
  • the opposing pinch members 34 in response to movement of the advancement element along the housing 14, may rotate with respect to the advancement element and the housing 14.
  • the opposing pinch members 34 in response to movement of the advancement element along the housing 14, may rotate with respect to the advancement element and the housing 14.
  • an inner surface of the advancement element may include one or more bumps 36 in contact with the opposing pinch members 34, which may reduce friction as the opposing pinch members 34 rotate.
  • the wedge 32 and/or the opposing pinch members 34 may be lubricated with a lubricant, which may reduce friction.
  • the opposing pinch members 34 may be constructed of plastic, metal, or another suitable material.
  • the opposing pinch members 34 may include spherical balls, ball bearings, wheels, or cylinders, which may be configured to rotate with respect to the advancement element.
  • the opposing pinch members 34 may include the wheels, which may be smooth or include feet along their edges. In these embodiments, lubricant may be applied to axels of the wheels to reduce friction.
  • the opposing pinch members 34 may be fixed with respect to the advancement element 12. For example, the opposing pinch members 34 may be molded into the advancement element 12.
  • a number of the opposing pinch members 34 may vary based on a shape of the wedge 32.
  • the vascular access device 10 may include the pair of opposing pinch members 34a, b and the other pair of opposing pinch members 34c, d in response to the shape of the wedge 32 being cylindrical, for example.
  • the vascular access device 10 may include a single pair of the opposing pinch members 34, such as the pair of the opposing pinch members 34a, b, in response to the wedge 32 including a dog bone shape, and the single pair may be disposed in a middle or depression of the dog bone shape.
  • the distal end of the guidewire 16 may include a spring or coil 37, which may facilitate movement of a thrombus within the catheter assembly while also allowing fluid to flow the distal end of the guidewire 16.
  • the spring or coil 37 may include varying pitches along a length of the spring or coil. For example, a pitch of the spring or coil 37 upstream from or proximal to the catheter distal tip may be larger to facilitate more blood flow and increase flow rate, and a pitch of the spring or coil 37 configured to be positioned near the catheter distal tip may be smaller to prevent blood clots from entering the catheter distal tip, while still allowing blood to flow through the catheter distal tip.
  • the guidewire 16 may include a rod 38, which may extend through a center portion of the spring or coil 37. In some embodiments, the distal end of the guidewire 16 may include the rod 38 and may not include the spring or coil 37.
  • the wedge 32 may be oval shaped, which may include a generally-oval shape. In some embodiments, rounded edges of the oval shape may facilitate an ability of the wedge 32 to round comers.
  • the wedge 32 may be monolithically formed as a single unit with a distal end of the guidewire 16.
  • the proximal end of the guidewire 16 may be tapered or stepped outwardly such that an enlarged outer diameter forms the wedge 32.
  • the wedge 32 may be secured to the rod 38 with an adhesive, a weld, a press fit, a crimp, a wrapped wire, or other suitable mechanism.
  • the wedge 32 may be formed by melting the wedge 32 into a desired shape onto the guidewire 16.
  • the distal end of the guidewire 16 may be constructed of metal, which may facilitate bending and/or flexibility to displace the thrombus.
  • the wedge 32 may be constructed of metal, plastic, or another suitable material.
  • the wedge 32 may include a bead, which may be constructed of metallic, plastic, or another suitable material.
  • the bead may be welded on the guidewire 16 to form the wedge 32.
  • the bead may be crimped on the guidewire 16 to form the wedge 32.
  • the bead may be secured to the guidewire 16 in another suitable manner.
  • the wedge 32 may be cylindrical, which may include a generally cylindrical shape.
  • opposing faces of the generally cylindrical shape of the wedge 32 may facilitate contact of the wedge 32 with the housing 14 when the housing 14 is pinched by the pair of opposing pinch members 34a, b and/or the other pair of opposing pinch members 34c, d.
  • an outer surface of the wedge 32 may include one or more fenestrations or grooves 39 configured to allow fluid to pass through the wedge 32.
  • blood may flow proximally through the housing 14 and into the blood collection container.
  • the grooves 39 may be straight and aligned with a longitudinal axis of the housing 14, which may facilitate a reduced blood collection time.
  • the housing 14 may include a single lumen through which blood may flow.
  • the housing 14 may include the single lumen and blood may flow through or around the wedge 32.
  • the housing 14 may be multi lumen, and blood may flow in a separate lumen from the wedge 32.
  • the wedge 32 may include one or more fins 40.
  • the fins 40 may facilitate fluid or blood to travel proximally through the housing 14 while also facilitating contact of the wedge 32 with the housing 14 when the housing 14 is pinched by the pair of opposing pinch members 34a, b and/or the other pair of opposing pinch members 34c, d.
  • the advancement element may include an aperture 41 extending therethrough and configured to receive the housing 14.
  • the inner surface of the advancement element may include one or more protrusions 42, which may contact the housing 14 to reduce friction between the housing 14 and the advancement element 12 as the advancement element 12 moves along the housing 14.
  • the advancement element 12 may include multiple pieces 44a, b, which may be coupled together via one or more pegs 45 or any other suitable mechanism.
  • the advancement element 12 may be monolithically formed as a single unit.
  • the advancement element 12 may include multiple cutouts 46, which may include the bumps 36.
  • the opposing pinch members 34 may include the spherical balls.
  • the cutouts 46 may be generally spherical and/or may extend outwardly from the aperture 41. In some embodiments, halves of the cutouts 46 illustrated in the multiple pieces 44a, b may be joined together to form the cutouts 46.
  • the advancement element 12 may be rigid or semi-rigid to facilitate gripping and/or one-handed advancement by the user.
  • the advancement element 12 may include one or more grip features or a shape to facilitate gripping by the user.
  • the grip features may include one or more of ridges, indents, and tabs on a top of the advancement element 12 and/or one or more sides of the advancement element 12.
  • the shape of the advancement element 12 may include a square, cylinder, dog bone, or another suitable shape.
  • the shape of the advancement element 12 and/or the grip features may facilitate the user advancing and/or retracting the guidewire 16 without contacting the guidewire 16, thereby decreasing a risk of contamination and/or infection.
  • the advancement element 12 may include one or more textured surfaces to facilitate gripping by the user.
  • the wedge 32 may be spherical, which may include a generally-spherical shape. In some embodiments, the wedge 32 that is spherical may facilitate smooth movement of the wedge 32 within the lumen 31.
  • the proximal end of the guidewire 16 may include a looped portion 48 formed by the guidewire 16.
  • the guidewire 16 may be disposed within the lumen 31.
  • the pair of opposing pinch members 34 in response to moving the advancement element 12 distally along the housing 14, may be aligned with an opening 50 formed by the looped portion 48 and may advance the guidewire 16 distally.
  • the pair of opposing pinch members 34 may pinch or compress the housing 14 such that the housing 14 is disposed within the opening 50.
  • the housing 14 may stay within the opening 50.
  • the looped portion 48 may include a single loop 51 or no more than one loop, which may be circular or ovular.
  • the guidewire 16 may include a twist portion 52, which may be proximate the looped portion 48.
  • a first end 54 and a second end 56 of the looped portion 48 may be twisted together to form the twist portion 52.
  • an entirety of the guidewire 16 may be monolithically formed as a single unit.
  • the guidewire 16 may be constructed with a single strand of metal or another suitable material.
  • the looped portion 48 may include multiple loops that may be stacked on top of each other.
  • the guidewire 13 may be wrapped around an axis to form the loops.
  • the axis may be generally perpendicular to a longitudinal axis of the guidewire 13 and/or the longitudinal axis of the housing 14.
  • each of the loops may be circular or ovular, which may facilitate pinching by the pair of opposing pinch members 34.
  • the loops may include one or more of a first loop 58, a second loop 60, and a third loop 62. In some embodiments, the loops may include more than three loops.
  • the second loop 60 and/or the third loop 62 may increase a width of the proximal end of the guidewire 16 to be pinched by the pair of opposing pinch members 34, and thus may facilitate the lumen 31 being wider and configured for greater blood flow.
  • the looped portion 48 may be coated with a coating 63, which may decrease friction between the looped portion 48 and the housing 14.
  • the coating 63 may include a lubricant.
  • the loops may include the first loop 58 and the second loop 60, and the first end 54 of the looped portion 48 may be proximate the first loop 58 and the second end 56 of the looped portion 48 may be proximate the second loop 60.
  • the loops may include the first loop 58, the second loop 60, and the third loop 62, and the second loop 60 may be in between the first loop 58 and the third loop 62.
  • the first end 54 of the looped portion 48 may be proximate the first loop 58 and the second end 56 of the looped portion 48 may be proximate the third loop 62.
  • the proximal end of the guidewire 16 may include a coiled portion 64.
  • the coiled portion 64 may be coiled around an axis generally parallel or aligned with a longitudinal axis of the guidewire 16 and/or the rod 38.
  • each coil in the coiled portion 64 may contact an adjacent distal coil and/or an adjacent proximal coil of the coiled portion 64, such that the wedge 32 is compact.
  • the wedge 32 may be welded at one or more of the following locations to prevent stretching or separation of the coiled portion 64: a proximal end of the coiled portion 64, a distal end of the coiled portion 64, and between the proximal end of the coiled portion 64 and the distal end of the coiled portion 64.
  • the distal connector 24 may be configured to couple to a catheter assembly 66, which may be existing or already dwelling within the vasculature of the patient.
  • the catheter assembly 66 may include a catheter adapter 68, which may include a distal end 70, a proximal end 72, and a lumen extending through the distal end 70 of the catheter adapter 68 and the proximal end 72 of the catheter adapter 68.
  • a catheter 74 may extend from the distal end 70 of the catheter adapter 68.
  • the catheter 74 may include a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter.
  • the catheter assembly 66 may include an introducer needle (not illustrated), which may extend through the catheter 74 and facilitate piercing of skin and the vasculature to insert the catheter 74 into the patient.
  • the introducer needle may be removed from the catheter assembly prior to coupling of the vascular access device 10 to the catheter assembly 66.
  • the catheter assembly 66 may be straight, as illustrated, for example, in Figure 8B.
  • the catheter assembly 66 may include a T- connector 76 and/or a needleless access connector 78.
  • the distal connector 24 may be directly coupled to the T-connector 76 or needleless access connector 78.
  • blood may be configured to flow proximally through one or more of the following: the catheter 74, the catheter adapter 68, the T-connector 76, the needleless access connector 78, the distal connector 24, the housing 14, and the proximal connector 30.
  • a blood collection device 80 may be coupled to the proximal connector 30 as mentioned previously.
  • the blood collection device 80 may include a syringe, a BD VACUTAINER ® one-use holder (available from Becton, Dickinson and Company of Franklin Lakes, New Jersey), a BD VACUTAINER ® LUER- LOKTM access device (also available from Becton, Dickinson and Company of Franklin Lakes, New Jersey), or another suitable blood collection device, which may provide suction.
  • the guidewire 16 In response to movement of the advancement element 12 from the retracted position to the advanced position, the guidewire 16 may be configured to extend beyond the catheter distal tip.
  • the catheter assembly 66 may be integrated, having an extension tube 82 that may be integrated with the catheter adapter 68.
  • the catheter assembly 66 may include an extension set, which may include the extension tube 82 extending from and integrated with a side port 84 of the catheter adapter 68.
  • the extension tube 82 may be coupled to the T-connector 76, which may be coupled to the needleless access connector 78.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Biophysics (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Manufacturing & Machinery (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Un dispositif d'accès vasculaire peut comprendre un élément d'avancement et un boîtier. Le boîtier peut être traversé par une lumière qui peut servir à la collecte de sang. Le dispositif d'accès vasculaire peut comprendre une paire d'éléments de pincement opposés conçus pour pincer le boîtier. La paire d'éléments de pincement opposés peut être conçue pour se déplacer le long du boîtier avec l'élément d'avancement. Le dispositif d'accès vasculaire peut comprendre un fil-guide qui peut comprendre un embout. En réponse à un déplacement distal de l'élément d'avancement le long du boîtier, la paire d'éléments de pincement opposés peut déplacer l'embout de manière distale et le fil-guide peut être avancé de manière distale. L'extrémité proximale du fil-guide peut comprendre une partie en boucle, et en réponse à un déplacement distal de l'élément d'avancement le long du boîtier, la paire d'éléments de pincement opposés peut être alignée avec une ouverture formée par la partie en boucle et faire avancer le fil-guide de manière distale.
PCT/US2022/035196 2021-07-02 2022-06-28 Dispositif d'accès vasculaire à avancement de fil-guide sans contact WO2023278363A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP22834018.8A EP4363023A1 (fr) 2021-07-02 2022-06-28 Dispositif d'accès vasculaire à avancement de fil-guide sans contact
JP2024500002A JP2024524504A (ja) 2021-07-02 2022-06-28 非接触ガイドワイヤアドバンスメントを有する血管アクセスデバイス
MX2023015389A MX2023015389A (es) 2021-07-02 2022-06-28 Dispositivo de acceso vascular con avance de alambre guia sin contacto.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163218143P 2021-07-02 2021-07-02
US63/218,143 2021-07-02

Publications (1)

Publication Number Publication Date
WO2023278363A1 true WO2023278363A1 (fr) 2023-01-05

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PCT/US2022/035196 WO2023278363A1 (fr) 2021-07-02 2022-06-28 Dispositif d'accès vasculaire à avancement de fil-guide sans contact

Country Status (6)

Country Link
US (1) US20230001156A1 (fr)
EP (1) EP4363023A1 (fr)
JP (1) JP2024524504A (fr)
CN (2) CN115554560A (fr)
MX (1) MX2023015389A (fr)
WO (1) WO2023278363A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5201714A (en) * 1992-03-05 1993-04-13 Conmed Corporation Laparoscopic cannula
US20030181870A1 (en) * 2002-03-19 2003-09-25 Becton, Dickinson And Company Needle device
US20200030581A1 (en) * 2015-10-28 2020-01-30 Becton, Dickinson And Company Compliant catheter adapter having self-slitting needle
WO2021195054A1 (fr) * 2020-03-27 2021-09-30 Becton, Dickinson And Company Ensemble d'extension et procédés et systèmes associés
US20220218955A1 (en) * 2021-01-13 2022-07-14 Becton, Dickinson And Company Vascular Access Instrument Advancement Devices, Systems, and Methods

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5201714A (en) * 1992-03-05 1993-04-13 Conmed Corporation Laparoscopic cannula
US20030181870A1 (en) * 2002-03-19 2003-09-25 Becton, Dickinson And Company Needle device
US20200030581A1 (en) * 2015-10-28 2020-01-30 Becton, Dickinson And Company Compliant catheter adapter having self-slitting needle
WO2021195054A1 (fr) * 2020-03-27 2021-09-30 Becton, Dickinson And Company Ensemble d'extension et procédés et systèmes associés
US20220218955A1 (en) * 2021-01-13 2022-07-14 Becton, Dickinson And Company Vascular Access Instrument Advancement Devices, Systems, and Methods

Also Published As

Publication number Publication date
CN219290384U (zh) 2023-07-04
EP4363023A1 (fr) 2024-05-08
JP2024524504A (ja) 2024-07-05
MX2023015389A (es) 2024-02-20
US20230001156A1 (en) 2023-01-05
CN115554560A (zh) 2023-01-03

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